Imaging systems and methods

ABSTRACT

X-ray and fluoroscopic image capture and, in particular, to a versatile X-ray emitter operative to capture images of a target configured to track and position the X-ray emission relative to an image sensor that generates the X-ray image using the X-ray emission. The system is configured to prompt the user or operator of the X-ray system with various informational data to improve the outcome of the X-ray and decrease the frequency of X-ray emissions required to obtain a desirable X-ray image.

REFERENCE TO RELATED APPLICATIONS

This application is a continuation of International Patent ApplicationPCT/US2023/064829 filed Mar. 22, 2023, which claims priority to U.S.Provisional Application 63/269,774 filed Mar. 22, 2022, the entiretiesof which are incorporated by reference herein.

FIELD OF THE INVENTION

Improved methods and systems for X-ray and fluoroscopic image captureand, in particular, to a versatile X-ray emitter operative to captureimages of a target configured to track and position the X-ray emissionrelative to an image sensor that generates the X-ray image using theX-ray emission. The system also prompts the user or operator of theX-ray system with various informational data to improve the outcome ofthe X-ray and decrease the frequency of X-ray emissions required toobtain a desirable X-ray image.

BACKGROUND OF THE INVENTION

The availability of a small, lightweight X-ray system that allows theX-ray operator or surgeon to manipulate an X-ray emitter while thesystem tracks the emitter position relative to the image sensor or workspace offers increased safety to the individual as well as the operatorgiven that the resulting positioning data prevents inadvertent X-rayemission as well as reducing the need for obtaining multiple X-rayimages due to inadequate positioning of the X-ray emitter relative tothe detector. Such systems also will use the positioning system to showa dynamic view of the X-ray detector or working space that contains theX-ray detector. This real-time, dynamic view can give the operator apicture of the anatomy imaged before generating the X-ray and alsoprovides a system that is capable of guiding an operator to specificX-ray views by overlaying a diagram of the subject anatomy directly onthe camera view, corrected for the active area of the detector.

SUMMARY OF THE INVENTION

The invention relates to an improved versatile, multimode radiographicsystems and methods, allowing the surgeon to operate on a patientwithout interference, and capture static and dynamic X-rays and otherstill and video imagery without repositioning equipment, the subject, orthe surgeon.

X-ray systems are described herein that allow for safely obtaining X-rayimages as well as aiding the operator of the system to obtain one ormore standard X-ray images of an individual or a body part that is laterexamined by a medical caregiver. It is noted that, in addition toimproving care of human patients, the systems and methods describedherein can also be used for X-ray imaging of objects and other animalsas well.

In some clinical scenarios, such as where the operator inexperienced oris not a physician, the X-ray system can draw from a reference libraryor database to provide information that helps users capture the bestviews. In some variations, the system will display a reference x-ray(e.g., an ideal X-ray image), an orthogonal reference photo, and apatient alignment photo. For example, in a shoulder x-ray exam, thestandard views of a shoulder exam are an AP view, Normal Y-view, and aNormal axial view. These views can sometimes be hard to capture foruntrained operators. By providing informational images and data from areference library, the improved X-Ray system can guide the user throughthese series of views and positioning of the patient, body part, and/oremitter. In addition, as the views are recorded, artificial intelligencecan determine if the captured x-rays match the requested x-rays for eachof the views. If a view does not meet the similarity score of thereference if a captured X-ray image does not meet the similarity scoreof the reference x-rays, the device system can alert the operator for areshoot to reduce physician intervention.

In some variations, the present disclosure includes a method ofobtaining a radiological image of an individual or a body part by anoperator, the method including: positioning an emitting apparatus at adistance from a working surface, where the working surface includes animaging sensor, the emitting apparatus including a camera system and anaperture opening configured to pass an emission energy therethrough;orienting the emitting apparatus such that the aperture opening and thecamera system face towards the working surface; transmitting a signalfrom the camera system to a display to produce an image of the workingsurface on the display; providing at least one informational image onthe display for viewing by the operator, where the at least oneinformational image includes a suggested positioning of the individualor the body part; and emitting the emission energy to the imaging sensorto produce the radiological image of the individual or the body part anddisplaying the radiological image on the display. Variations of themethod and systems include a display that is located on the emittingapparatus and/or a display located on a separate monitor.

An additional method described for obtaining a radiological image of anindividual by an operator, includes: providing an emitting apparatushaving a display, a camera system, and an aperture opening configured topass an emission energy therethrough; displaying an anatomicrepresentation on the display, where the anatomic representationincludes one or more anatomic areas, where the display is configure topermit the operator to identify a selected anatomic area from the one ormore anatomic areas; providing at least one informational image on thedisplay for viewing by the operator, where the at least oneinformational image corresponds to the selected anatomic area, where theat least one informational image includes a suggested positioning of abody part corresponding to the selected anatomic area; positioning theemitting apparatus at a distance from a working surface, where theworking surface includes an imaging sensor; orienting the emittingapparatus such that the aperture opening and the camera system facetowards the working surface; transmitting a signal from the camerasystem to a display to produce an image of the working surface on thedisplay; and emitting the emission energy to the imaging sensor toproduce a radiological image of the body part and displaying theradiological image on the display.

The methods can include providing a virtual anatomical representation ofthe body part on the image, where the virtual anatomical representationis overlaid on the working surface on the image. The methods can alsoinclude positioning the body part on the working surface using thevirtual anatomical representation.

In variations of the system, the imaging sensor includes a detectingperimeter, and variations of the system and methods include displaying avirtual detecting perimeter on the display, where the virtual detectingperimeter is overlaid on the working surface and corresponds to thedetecting perimeter. The system and methods can also display a virtualemission perimeter on the display, where the virtual emission perimeteris overlaid on the working surface and corresponds to an emissionperimeter of the emission energy from the aperture opening.

The informational image can further include providing an instructionalmessage on the display. For example, the instructional message caninclude a text instruction or a video instruction.

Moreover, the systems and methods can comprise showing a video image ofthe workspace and/or the anatomy of the subject being examined.Alternatively, or in combination the systems and method can include atleast one non-video image of the subject/objects.

The system and methods disclosed herein can further include providing aninformational data on the display, where the informational data includesa data associated with the individual.

The systems and methods can show a plurality of subset displays, whereinthe image of the working surface is displayed on a first subset displayand wherein the radiological image is displayed on a second subsetdisplay. In some variations, at least one informational image isdisplayed on a third subset display.

The methods and systems of the present disclosure can include providingat least one informational image includes selecting one or more imagesfrom a first database containing a plurality of radiographic imaginginformation.

In some variations, the methods described herein can further include,prior to positioning the emitting apparatus, displaying an anatomicrepresentation on the display, the anatomic representation having one ormore anatomic areas, where the display is configure to permit theoperator to select one or more of anatomic areas to pre-select the atleast one informational image provided on the display for viewing by theoperator.

The methods and system described herein can further include performing acomparison of the radiological image to a reference radiological imageand providing feedback to the operator based on the comparison.

The present disclosure includes systems for obtaining a radiologicalimage of a body part on a working surface having an X-ray image sensor.For example, one such system includes: an emitting apparatus including acamera system and an aperture opening configured to pass an emissionenergy therethrough, where the emitting apparatus includes a displayconfigured to show an image of the working surface generated by thecamera system; the emitting apparatus configured to communicate with adatabase containing a plurality of radiographic imaging information datato display at least one informational image for viewing by the operator,where the at least one informational image includes a suggestedpositioning of the body part; and where the display configured to show avirtual anatomical representation of the body part on the image of theworking surface, and where the display is configured to provide theradiological image after the emission energy is emitted on the body partand the X-ray image sensor.

In some variations, the present disclosure includes a system, whereinthe emitting apparatus is in communication with a first databasecontaining a plurality of radiographic imaging information and where theat least one informational image includes one or more images from thefirst database containing a plurality of radiographic imaginginformation.

This application is related to the following: U.S. Pat. Nos. U.S. Ser.No. 10/076,302 issued on Sep. 18, 2018, U.S. Ser. No. 11/207,047 issuedon Dec. 28, 2021, and U.S. Ser. No. 11/382,582 issued on Jul. 12, 2022,and U.S. Patent Application no: US20200289207, published Sep. 17, 2020.The entirety of each of which is incorporated by reference.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A depicts an example of an operating room layout for the use ofthe X-ray imaging system in a standard surgery of an extremity case.

FIGS. 1B and 1C depict an alternate example of an operating room layoutfor the use of the imaging system with a specialized operating tablethat improves access to an area of a patient.

FIG. 2 is a simplified schematic representation of an X-ray emitteraccording to the invention.

FIG. 3 illustrates one embodiment of a control panel for use with anemitter.

FIG. 4 shows a safety lockout procedure for an X-ray emitter.

FIG. 5 depicts a representative sequence for emitter power management.

FIG. 6 illustrates a process by which a device captures concurrentimages at the request of a user.

FIG. 7 is a drawing that illustrates the overall components of avariation of a capture stage.

FIG. 8A is an oblique view of a sensor positioning system.

FIG. 8B illustrates infrared (IR) positioning tiles. from above.

FIG. 9 is a diagram that shows x, y movement of a sensor tray viewedfrom above.

FIG. 10A is an oblique diagram showing a band-operated image capturestage.

FIG. 10B is a schematic diagram of a band-operated stage with anidentification of important components.

FIG. 11A is a side view showing a sensor tilt operation.

FIG. 11B is a side view showing a sensor panning operation.

FIG. 12A illustrates an arrangement whereby an emitter need not beprovided on an image stage platform.

FIG. 12B illustrates additional arrangements of the imaging system wherea sensor can be configured to capture lateral views by moving above aplane of the table.

FIG. 13 is a view of an infrared emission device emitting infrared from5 points allowing for relative position calculation in 3-dimensionalspace.

FIG. 14 illustrates a safety lockout of the capture stage based upon thedisposition of the emitter.

FIG. 15 illustrates the capture of a fluoroscopic image.

FIG. 16 is a view showing the X-ray emission device with an aperturecreating the widest cone.

FIG. 17 shows a view showing the X-ray emission device with an aperturecreating a narrow cone.

FIG. 18 shows a control unit operative to adjust the aperture and cone.

FIG. 19 is a labeled view illustrating relative distances.

FIG. 20 illustrates a situation where an emitting apparatus casts anenergy profile that exceeds a profile of an imaging sensor.

FIG. 21A represents a situation in which an emission profile extendsbeyond a sensor such that the emitter is not in operative alignment withthe sensor.

FIG. 21B represents a situation in which an emission profile is scaledto remain within a perimeter of an imaging sensor and is in operativealignment with the sensor.

FIGS. 22A and 22B illustrate an example of the effect of an adjustablecollimator to produce an adjusted emission profile that is scaled and/orrotated to remain within the perimeter of an imaging sensor.

FIG. 23 shows a variation of an adjustable collimator that can be usedin or with an emitting apparatus.

FIG. 24 illustrates an example of a traditional automatic exposureprocess.

FIG. 25 illustrates an improved system that relies upon one or moredatabases to provide machine learning for determination of exposuresettings for a radiological image.

FIG. 26 illustrates a process of improving the automatic exposureprocess and databases using feedback from the systems described herein.

FIG. 27 shows an additional variation of an X-ray system usingnon-line-of-sight-tracking-elements such as electromagnetic trackingsensors.

FIG. 28 illustrates another variation of an imaging system as describedherein that uses a portable X-ray emitter and monitor to display one ormore virtual images to assist in obtaining an X-ray image.

FIGS. 29 and 30 illustrate the initial stages of an attempt to capturean X-ray image of an individual patient that is adjacent to an imagesensor of an obscured image sensing housing.

FIG. 31 represents a display of a first virtual representation of theboundary of the imaging sensor on the display.

FIGS. 32 and 33 show additional examples of images overlayed withvirtual images of the boundary of an imaging sensor.

FIGS. 34A to 34C shows another variation of an emitter having a screenthat allows operation of the emitter and observation of the monitor intwo configurations.

FIG. 35 illustrates a tablet-type emitter for improving the ability ofan operator to take an X-ray image.

FIGS. 36A TO 36C illustrates an example of a system as described in FIG.35 with various information displayed in a display of thetablet-emitter.

FIGS. 37A TO 37C illustrate examples of database information that can beprovided to various X-ray systems to improve the ability of anindividual to obtain one or more X-ray images.

FIG. 38 illustrates an additional variation of a display configured toassist an operator to obtain a radiographic image at an initialscreening of an individual

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

FIG. 1A depicts an example of an operating room layout for the use of animaging system in a standard surgery of an extremity case. In thisexample, the surgeon 102 is operating on the patient's left hand. Thepatient 104 is lying in the supine position with the left upperextremity prepped and draped on a hand table 105 in the abductedposition. The surgeon sits adjacent to the patient's side while asurgical assistant 106 sits across the hand table adjacent to thepatient's head. Surgical instruments and equipment are laid out on theback table 108 immediately behind the surgical assistant.

In one variation, the imaging system uses X-ray imaging. As such, asterilized X-ray emitter 110, according to the invention, is placed onthe surgical hand table 105 for use. A monitor 112 is positioned on astand immediately adjacent to the hand table whereby X-ray,fluoroscopic, thermal, and digital images can be wirelessly transferredfrom the X-ray imaging system to the screen for surgeon view. Theemitter 110 allows the surgeon to hold it with one hand while operatinganother instrument, such as a drill in the other hand. A detector stage,according to the invention, may be placed on or in the table 105 togather radiographic imagery for storage and/or viewing on an externalmonitor such as device 112. As discussed herein, the emitter can behandheld or can be affixed to a mounting structure that is eitherautomated/controllable or simply bears the weight of the emitter toprevent the user from constantly holding the emitter.

FIG. 1B illustrates an additional variation of a system including asensor 706 and an emitter 710 for use with a specialized operating table300. As shown, the operating table 300 includes structures 302 thatstabilize the patient while allowing increased access around thepatient's organs since a portion of the organ is suspended in freespace. In this variation, a shell 707 containing the sensor 706 (asdiscussed below) is coupled to a first boom or arm 716. The arm/boom 716allows for movement of the sensor 706. In an alternate variation, theboom 716 can be automated such that the sensor 706 is coupled directlyto a controllable boom 716. Likewise, the emitter 710 is coupled to asecond arm or boom 714 that can be affixed to a wall, ceiling, orportable frame structure. FIG. 1C illustrates positioning of the sensor706 and boom 716 adjacent to a body part of the patient 104 such thatthe emitter 710 can be positioned as desired by the operator or medicalpractitioner. In variations of the system, the boom or arm can alsohouse components of the device, such as a heat sink, power supply, etc.,allowing for a more compact and easy to maneuver emitter. In addition,either boom can be designed with features to aid the physician inperforming the procedure. For example, the boom can incorporate alocking system so that the physician can position either the sensor 706and/or emitter 710 and then lock the associated boom into position.Additionally, or in combination, booms can incorporate memorypositioning such that the boom can automatically retract away from thesurgical space to a pre-determined location such that it automaticallymoves out of the way of the physician when performing a procedure. Inaddition, memory locations can include the “last location” of theemitter or sensor, such that the system can automatically reposition thecomponents in their last position prior to being moved away from thesurgical space.

As discussed herein, the systems described herein can include one ormore distance sensors 708 located on the image sensor and/or theoperating table or other region of the working area. The distancesensor(s) 708 allows measurement of any space between the body part oranatomy placed on the image sensor, operating table, and/or workingarea. As noted below, such an additional measurement will allow correctmeasurement of the thickness of the body structure if there is a gap orspace between the image sensor, operating table, and/or working area andthe body structure.

FIG. 2 is a simplified schematic representation of an X-ray emitteraccording to the invention. The general configuration of the device isto be handheld, lightweight, and extremely portable. The devicepreferably has a rounded, contoured handle to ergonomically fit thesurgeon's hand and better direct fluoroscopy, digital and thermalimagery to the extremity and surgical field.

In one variation, the back of the emitter 110 can include a controlpanel where at least three different modes of operation can beactivated: fluoroscopic mode, digital picture mode, or infrared thermalimaging mode. Once activated, each mode is controlled in the front ofthe device by a trigger 202. Pressing the trigger once activates thedevice to take a single image (i.e., single X-ray or digital picture).Different modes of operation may be activated in different. As oneexample, holding the trigger 12 down may activate live fluoroscopy,digital video, or infrared thermal imaging. FIG. 2 also illustrates theemitter 110 as being coupled to a power supply 221. The power supply canbe a battery 221 located remotely from or within the emitter 110.Alternatively, or in combination, the power supply 221 can be coupledvia wiring between the emitter 110 and power supply 221. In anadditional variation, the battery 221 can be positioned within theemitter 110 and used in addition to a remote power supply 221 such thatthe emitter 110 can be disconnected from the external power supplytemporarily, with the internal battery 221 used to provide power.

FIG. 3 illustrates one embodiment of the control panel for use with theemitter. The control panel is located on the rear of the emission handleand controls the various inputs and outputs of the system. The controlpanel is easily accessible for the user and is ergonomically designed toease the manipulation of the emitter. The control panel comprises alarge, clear screen 204 (i.e., LCD or OLED), a control button 302located on the left of the unit, a control button 304 located on theright of the unit, and a center, clickable toggle button 206 located inthe center.

Display screen 204 displays images and a digital control panel tocontrol fluoroscopic, digital camera and infrared settings. The controlpanel may include a touch screen. Toggle button 206 controls power inputin fluoroscopic and infrared modes and digital zoom in the picture mode.One variation of an emitter configuration houses a dynamic X-raycollimating cone 210, digital camera lens 212, infrared camera 214 anddistance sensor 216. The digital and infrared cameras preferable usecharge-coupled device (CCD) technology. The distance sensor may beinfrared, acoustic or other operative technology known to those of skillin the art of proximity and distance measurement. The sensor 216continuously senses its distance from the patient and will block theactivation and discharge of radiation if the X-ray tube is too close,for example, if less than 19 centimeters directly from a patient. Inaddition, the system can include any number of auditory, visual, ortactile indicators to allow a physician or user of the system todetermine that the sensor is within an acceptable distance or ready tofire. In additional variations, the auditory, visual, and/or tactileindicators are positioned such that the operative state of the system isidentifiable without the need for the user to remove his/her focus fromthe object being examined. In one example, a visible indicator one ormore LEDs) is positioned on the emitter, which provides clearlydistinguishable feedback regarding the distance, alignment, or any otheroperational conditions of the system.

The handle 200 tapers to the bottom of the device, which may househigh-voltage power supply 218, external charging port 220, and batterydocking station 222. Upon activation of the trigger 202 in X-ray orfluoroscopic modes, high voltage from power supply 218 is fed to X-raygeneration unit 230 via the high voltage connector assembly 228. Powerproduced by power supply 218 is converted to a suitable input voltagethat can be used by the X-ray generation unit 230. This power rangesfrom 1 kV to 120 kV but typically ranges between 30 kV to 90 kV inconjunction with clinical application.

The X-ray generation unit 230 is based upon existing high-voltageemitters, though custom-designed for small size required of the instantapplication. A suitable thickness of electrically insulating materialsurrounds the high voltage power supply 218, connector assembly 228 andthe X-ray generation unit 230 to prevent radiation loss and preservegood beam quality. All three components 218, 228, 230 are placedimmediately adjacent to each other to minimize high voltage leakage andpossible interference with low voltage components in the system. In analternative embodiment, components 218, 228, 230 may be disposed in anexternal control unit (not shown).

A suitable layered combination of silicone rubber and epoxy encapsulatesthe X-ray generation unit 230 (except where X-rays are emitted intocollimator) in order to shield radiation losses and dissipate hightemperatures generated by X-ray tube operation. Radiation is produced bythe X-ray tube and transmitted via the collimating cone 210 at the headof the device. Fluoroscopic settings include peak kilovoltage (kV),amperage (mA), and digital brightness, are controlled by the digitalcontrol panel on the back of the neck.

The digital camera lens 212 and infrared thermal camera 214 areimmediately adjacent to the collimating cone 210, and these componentsare also shielded by insulation. The digital camera 214 is controlled byplacing the device in digital mode using the control panel. Pictures aregenerated via the trigger 202 located on the device handle.

Similarly, the infrared thermal camera 214 is controlled by placing thedevice in infrared mode using the control panel. Live infrared thermalimaging is generated by holding the trigger down. Digital X-rays,traditional digital visible and thermal images may be transferred anddisplayed on the external screen 112 shown in FIG. 1 . Depending uponthe level of cooperation between the emitter and the detector describedherein, X-ray images may be transferred directly to the external monitorfor viewing. A memory 233 may be used to store any type of gatheredimage, and such images may be encrypted upon capture in accordance withco-pending U.S. patent application Ser. No. 15/466,216, the entirecontent of which is incorporated herein by reference. An audio pickup235 may be provided for procedure memorialization or other purposes, andthe recordings may also be stored in memory 233, optionally in encryptedform as well.

The device is powered by an external plugin power supply with externalcharging port 220. The digital display, control interfaces, and triggerare controlled via the control system microprocessor electronic controlunit 232 powered by a low voltage power amplifier system 234. The lowvoltage amplifying system 234 and the microprocessor control system 232are also conveniently located away from the high voltage power supply tofurther minimize interference.

The following Table lists the various control modes associated with theemitter using the buttons and toggle switch on the control panel of FIG.3 :

Mode Control X-Ray Digital Thermal Center (206) Switch to Switch toSwitch to X- Digital Thermal Ray Left Button (302) Increate OutputToggle Macro Decrease Power Exposure Right Button (304) Decrease OutputZoom In Increase Power Exposure

For a variety of reasons, both practical and certification, it isimportant to maintain a minimum distance between the subject and theX-ray generator. This distance can change depending on a number offactors and can be configured in the emitter's software. FIG. 4 shows aprocess by which the device manages a safety lockout procedure of theX-ray emitter. The process to determine the safety lockout is asfollows:

402. The user initiates the X-ray emission process by depressing thetrigger while in X-ray mode. This could be for either a fluoroscopic orstill X-ray image.

404. A distance setting is retrieved from the emitter's distance settingdatabase.

405. The distance measurement unit is activated and captures thedistance between the end of the emitter and the subject directly infront of the emitter.

406. The distance setting and distance measurements are relayed to theemitter's ECU Computation unit.

408. At 408, the ECU Computation unit uses the distance measurement,distance setting and an internal generator offset to determine if theemitter should fire.

410. The fire/warn decision at 410 is determined by the ECU and relayedto the hardware units.

412. At 412, if the ECU determines that the subject is too close to theemitter, the unit will activate a warning procedure, displaying amessage on the LCD panel and activating any lockout warning lights.

414. If at 414 the ECU determines that the subject is at a safedistance, the emitter will begin the X-ray generation and emissionprocess, signaling all internal and external components.

Due to the fact that the device can move freely in 3-dimensional space,the projected cone from the X-ray emitter varies in size based on thedistance to the target. As such, the invention allows managed controlover the cone size based on the distance of the X-ray emission devicefrom a sensor positioned on the stage.

FIG. 16 illustrates a simplified rendition of an applicable X-raysource, which includes an anode 1602 and cathode 1604. The anodetypically includes a tungsten or molybdenum target 1606. High voltageacross the anode and cathode causes x rays to be produced at the target,which forms a cone 1608 that exits through an aperture 1610 in casing1612.

One aspect of the invention includes a telescoping chamber positioned inthe direction of the aperture and sensor. The distance from the X-raysource to the output aperture can be increased or decreased by rotatingthe exterior chamber along a threaded interior mount. Moving theaperture closer to the source creates a wider angle, while moving itfarther from the source reduces the angle, as shown in FIG. 17 .

Making reference to FIG. 18 , a control unit 1802 in the handheldemitter controls the telescoping aperture. Based upon the process below,the control unit 1802 rotates a threaded shaft 1804, whereupon thethreads engage with grooves 1806 in telescoping chamber 1614, causingaperture 1610 to toward and away from the X-ray source.

FIG. 19 illustrates a control methodology. First, the distance betweenthe device's X-ray origin and the X-ray sensor is calculated. If thedistance is outside an acceptable range of X-ray emission, then noX-rays will be emitted. However, if the distance between the X-rayorigin and the sensor (d_(s)) are within the acceptable range, theaperture will be automatically moved into place. The distance betweenthe X-ray origin and the aperture (d_(a)) is then calculated, and thecontrol unit rotates the aperture chamber to the correct distance.

If R_(s) represents the radius of the X-ray emission as it contacts thesensor, then the angle between the normalized vector of the sensor plateand the dispersion cone can be represented as θ=tan⁻¹(R_(s)/d_(s)). Thedistance that the aperture will need to be located from the emissionorigin to emit the correct dispersion of X-rays can be calculated asd_(a)=R_(a)/tan(θ) where R_(a) represents the radius of the aperture.The control unit then allows the X-ray emission device to emit an X-raywhich projects a cone at an angle θ onto the sensor.

While the telescoping cone adjustment mechanism described with referenceto FIGS. 16-19 is an improved aperture, those of skill in the art willappreciate that a more conventional adjustable aperture (i.e., withtranslatable X-ray absorbing or blocking blades) can instead be used.The same math used above is applicable to this embodiment; that is, ifthe distance is outside an acceptable range of X-ray emission, then noX-rays will be emitted. Conversely, if the distance between the X-rayorigin and the sensor (d_(s)) are within the acceptable range, theaperture will be automatically opened or closed to facilitate firing ofthe source.

Different markets have different safety requirements. Additionally,depending on the subject (elderly, pediatric, otherwise healthy) thelockout may be adjusted to ensure that there are no safety issuesassociated with the emission. The device also preferably includes thecapability to intelligently conserve power by utilizing the inertialmeasurement unit (IMU), distance sensor unit, as well asoperator-initiated command inputs. The various durations for the powerstages of the unit are user-configurable so that the device can matchthe user's specific style and cadence.

The systems and methods described herein can also use multiple sensorsfor error correction and/or to improve positioning. For example, if anemitter and detector/sensor are in a given position and the system losestracking of one or more sensors on the platform. Ordinarily the loss intracking might cause a reduction in the frames per second (FPS) of theoutput image. To address this situation, the emitter can include one ormore inertial measurement units that can track movement of the emitterto adjust the intervening frame, especially when needed. The IMU willthen be used to adjust the intervening frames to increase the FPS of theoutput. In some variations, with IMU's of sufficient accuracy, the IMUcan be used in place of or in addition to sensors on the platform.

A representative sequence for power management is shown in FIG. 5 .

502. The user initiates the power sequence on the device by pushing aphysical button (i.e., 208 in FIG. 2 ) on the emitter. This engages thedevice's electronics and moves the device into ON mode.

504. Picking up the device is detected by the IMU in the emitter andimmediately raises the power level to STANDBY. This STANDBY stateinitializes all power systems and raises the charge of the power supplyto a medium level.

505. If the user sets the device down or is otherwise not interactedwith, either through movement of the emitter or through the initiationin the control panel or control computer, the device will automaticallypower down to the OFF stage after a duration of t0.

506. The user has picked up the unit and has engaged the unit, eitherthrough altering of settings on the control panel itself or by bringingthe device within range of a subject as detected by the onboard distancesensor. This further elevates the power level of the device by fullycharging the power system to a state where the device is ready to fire,bringing the device into READY mode.

507. If, after a duration of t1 without actively engaging the unit, theemitter will power itself down to the STANDBY level.

510. The user initiates an X-ray capture by depressing the trigger 202on the emitter. Assuming that all other safety checks are cleared, thisfurther engages the power supply and emits the stream of X-ray photonsat the subject until a state of 511, at which time the emission iscomplete. The user can continue to emit X-ray photons indefinitely at510′, 511′, however, as the device returns to READY mode.

511. After a duration of t2 during which time the emitter has not beenfired, the device will automatically power itself down to the STANDBYlevel at 520.

As shown with points 508, 522, 524, the device will follow the abovetimings to transition the device from the ON stages and finally to theOFF stage as the various durations elapse without positive engagement tomaintain or change the power state. By utilizing these steps, the devicecan conserve power while maintaining in a ready state without anyinteraction from the user.

FIG. 6 illustrates a process by which the device captures concurrentimages at the request of the user. Using the settings on the emitter'scontrol screen, or by specifying a concurrent capture in the controlunit, the emitter will initiate a process to capture any combination ofX-ray, traditional digital and/or thermal images. The process to capturethe images is as follows:

602. The user initiates the capture sequence on the device by pullingthe trigger of the emitter. This begins the capture process andconcurrent imaging process for whatever grouping of sensors is enabled.

604. The emitter immediately engages the X-Ray standby mode, preparingto fire the X-ray generator.

604′. Concurrently, if enabled, the traditional camera component focuseson the desired subject. This preferably occurs as soon as the trigger isdepressed.

604″. Concurrently, if enabled, the thermal camera is powered on andbegins its start sequence. This also preferably occurs as soon as thetrigger is depressed.

606. The X-ray system begins its safety checks, as illustrated in FIG. 4.

608. The digital imaging camera captures a traditional image of thesubject. The image is preferably automatically transferred to thecontrol unit for display on an external monitor.

610. The thermal camera captures a thermal image of the subject. Theimage is preferably automatically transferred to the control unit fordisplay on an external monitor.

620. In one variation, after both 608 and 610 have completed, and allsafety checks from 606 have been verified, the X-ray unit will fire anemission, generating an X-ray image in the sensor. The image ispreferably automatically transferred to the control unit for display onan external monitor. Thus, the X-ray system will charge, verify safety,and discharge the X-ray only after all other systems have been executedto minimize operational interference.

X-Ray Detector Implementations

The emitter described herein must be used in conjunction with an X-raydetector to gather radiographic imagery. The emitter is not limited interms of detector technology, and may be used with any availableflat-panel detector, even film. However, given fully portable nature ofthe emitter, steps should be taken to ensure that the emitter isproperly oriented with respect to the detector to gather clear imagerywhile avoiding spurious or unwanted X-ray emissions. One option is tomount the emitter in a fixture including a properly aligned detectorplate, much like a traditional c-arm though much smaller and morecapable. Another option, however, is to use the emitter with the X-raycapture stages described below, one of which includes an embedded sensorthat automatically pivots, orients and aligns itself with the emitter tomaximize exposure quality and safety.

One variation of an X-ray capture stage includes a statically fixedplatform, positioned during the outset of surgery, with an interiorcavity containing an X-ray sensor, an X-ray sensor positioning system,an emitter tracking system, a shielding system and a control unit. TheX-ray capture stage is adapted to receive an X-ray emission from aseparate emitter device, including the portable, handheld unit describedherein. The X-ray capture stage preferably also incorporates wireless(or wired) communications capabilities enabling review of a capturedX-ray or fluoroscopic image on an external display monitor or any otherarrangement for the captured image including external storage.

There are broadly two capture stage embodiments. In a clinicalembodiment, the stage tracks the emission and simply locks out the X-rayfiring if it is not in line. A tracking stage embodiment also permits orlocks out emission in accordance with alignment, but also preciselytracks the position and angle of the X-ray emission, positioning andtilting the embedded sensor to capture a precise, high-quality X-rayimage. This arrangement uses less power, corrects for any skew orperspective in the emission and allows the subject to remain in place,thereby enabling the surgeon's workflow to continue uninterrupted andcapture X-rays without repositioning equipment, the subject or thesurgeon.

FIG. 7 is a simplified view of a variation of the X-ray capture stage,which includes a platform 702 with a hollow cavity including theembedded sensor 706. In one configuration, the stage might have legs 703and be used as a table. In another configuration, the stage might bewrapped in a bag and positioned underneath a patient. Thus, the platform702 can be wrapped in a sterile drape and surgical procedures can beperformed upon a platform, such as table 105 in FIG. 1 .

The capture stage cooperates with a separate X-ray emission device 710.There are a number of different configurations and implementations ofthe X-ray emission device besides the handheld unit described in detailabove, including wall-mounted, armature-mounted, and floor-mounted. Anyimplementation is compatible with the operative X-ray stage as long asthe electronic systems of the emitter can communicate with the interfaceof the operative X-ray stage central control unit to provide forpivoting, orientation or alignment.

The platform 702 is in electrical communication with a central controlunit 704. A display monitor 712, electronically connected to the controlunit 704, which may be used to both display images and provide overallsystem control. Generally, a user will interact with the emitter 710;however, in some cases, a user may interact with the central controlunit 704 directly to manipulate images, setup specific capturescenarios, control parameters or adjust other settings. The system mayalso use a tablet, mobile phone or any other display deviceelectronically connected to the central control unit for displaypurposes. The central control unit 704 and display may be combined in asingle device, such as a laptop computer or other mobile computingdevice. Optionally, the central control unit can be electronicallyconnected to multiple display units for educational or other purposes.

FIG. 8A is an oblique view of an X-ray capture stage according to theinvention. In one specific arrangement, the stage comprises a hollow,sealed shell that is roughly 20″×30″, although the overall size of theinvention can be changed to conform to other surgical applications. Theshell creates a cavity 800 housing an X-ray detection sensor 706operative to capture an X-ray emission from an X-ray emitter. SuitableX-ray sensors are available from a variety of commercial manufacturers.The sensor 706 is attached to a motorized movement system used to panand tilt the sensor within the cavity. This motorized system ensuresthat the sensor is precisely positioned for maximum image quality andcapture view.

The X-ray sensor 706 is preferably mounted to a movable tray 802 thattravels under controlled movement within the cavity 800. The tray andsensor can move in the x-y direction and tilt along both axes asdescribed below. FIG. 9 is a diagram of a capture stage seen from above.The sensor 706 in tray 802 is mounted to translate on a series ofmotorized rails 720, 722, allowing the sensor to position itselfanywhere along the x and y axis within the shell. At least one of the xand y tracks may be a threaded rod, for example, each being driven by amotor for precise lateral movement of the tray 802 in the x and ydimensions. As a further alternative, the x-y movement of the tray maybe controlled with bands 1002, 1004 in FIG. 10A. Such bands areprecisely controlled by rods 1006, 1008, causing tray supports 1110,1112 to translate tray 808. Note that while four tray supports 902, 904are depicted in FIG. 9 , single supports 1110, 1112 may alternatively beused as shown in FIG. 10A.

The emitters 830 are used to measure the distance from a point 810 onthe handheld unit 710 to three (or more) fixed points 830 on the stage.These distances are depicted as D₁, D₂ and D₃ in FIG. 8A. Based uponthese distances, the system employs a tracking method to preciselylocate a center point 801 on the sensor 706 and angle (θ₅) of theemission from the source to the platform. An exemplary implementation ofthis tracking system would include a combination of infrared sensorswithin the platform and the handheld unit, as well as a gyroscope in thestage and handheld unit to detect the angle θ₅.

The positioning of the detector uses a number of sensors in concert.When the user picks up the handheld unit, the system enters a readystate. The infrared beacons on the corners of the table illuminate. Thepositioning tracking camera on the handheld unit immediately startsanalyzing the infrared spectrum captured within a 140-degree field ofview. The camera is searching for patterns of infrared light. Eachcorner 830 has a specific pattern that determines which corner of thestage the infrared camera in the handheld unit is looking at.

Making reference to FIG. 8B, an IR positioning emitter tile 850 sits ateach corner of the operative or clinical stage. The diagram is anexample of four unique tiles. When using the mounted positioningbeacons, the pattern will be different. These tiles contain a number ofinfrared emitters 852, usually five individual emitters, arranged in aspecific pattern. Each tile contains a different pattern of the five IRemitters. As the operator moves the X-ray emitter around the stage, theIR positioning camera captures and analyses the IR emissions from thetiles. Because each tile has a unique pattern, the camera is able todetermine its exact position in relation to the table. Additionally,because each tile has a unique pattern of multiple lights, the systemcan determine the exact position from the tile in XYZ space.

Optionally, or in addition to this unique IR layout, the IR emitters canflash in a syncopated manner. By modulating the frequency of theflashes, it is possible to add an additional uniqueness signature toeach tile, allowing patterns to repeat in a scenario with a large numberof tiles. Because of this unique arrangement, only a single corner ofthe unit, or single positioning beacon, needs to be visible to theemitter to allow the system to fully function. That is, due to thelayout of the pattern, the camera can triangulate its position in spacerelative to each corner. By using the triangulation data, as well as theorientation data from the IMU unit on the emitter, the system candetermine the center point of the emission. The stage will then move thecenter point to that area of the stage and tilt the detector to be asperpendicular to the emission as possible. While the sensor is movinginto position, the collimator on the emitter adjusts the output of thebeam to ensure that it is illuminating the detector panel only.

The position information from the combination of the sensors 830 isrouted through the control unit (i.e., 704 in FIG. 7 ), whichinterpolates the raw sensor data into an aim point on the platform. Theplatform then moves the sensor tray 802 to the specified point. Theplatform then tilts the sensor into the correct orientation (θ₅) toremove as much skew as possible. Stated differently, assuming the X-raysource in emitter 710 emits radiation with respect to an axis 803, thegoal is to place the axis 803 as close as possible to the center point801 of the sensor, with the plane of the sensor being as perpendicularas possible to the axis 201 to minimize skew.

In all stage embodiments, the upper cover of the platform or shell iscovered with a radiolucent material (i.e., 1018 in FIG. 10A). However,the lower base of the platform (i.e., 1020 in FIG. 10A) is preferablycoated with an X-ray absorbing material such as lead. This coatingprevents the excess X-rays from penetrating through the field and beingabsorbed by the operator of the emitter. This X-ray absorbingundercoating also prevents excess X-ray emission from bouncing off thefloor and scattering throughout the facility. The sides of the platformmay be constructed from a radio-opaque material as well.

FIG. 10B is a schematic diagram of a band-operated stage with anidentification of important components. The X-ray detector is shown at1030, and the detector carrier is depicted at 1032. This particularembodiment is driven by an H-shaped belt 1040. Items 1042 and 1044 aresmall and large offset bearings, respectively. The belt is driven bymotors 1050, 1052. The stage housing is shown at 1060, and power isbrought in via cable 1062. The detector tilt motors are indicated at1070, 1072. IR positioning tiles and IR emitters described withreference to FIG. 8B, are shown at 850 and 852, respectively. Thetypical IR emitters described herein are active beacons since theyactively emit a signal or energy that is received by the emitter to aidin determining a position of the emitter. Alternatively, or incombination, additional variations of the methods, systems, and devicesdescribed herein can include passive markings or objects to aid indetermining orientation of the emitter. The systems, devices and methodcan include camera or emitter that simply record a specific pattern(e.g., a QR symbol or some unique object in the surgical area such as aclock, table, fixture, etc.). The system will then rely on a computer touse these patterns in place of, or in combination with, IR beacons todetermine a position of the emitter. In this latter case, the emitterposition is calculated by the computer or other processing unit.

FIGS. 11A, 11B are diagrams that show a pan and tilt mechanism. In FIG.11A, the sensor tray 802 is positioned within the cavity and the sensor706 is tilted around the y-axis. In FIG. 11B, the sensor tray 802 istilted along both the x-axis and the y-axes. This panning and tiltingallow the sensor to be precisely positioned to capture an X-ray imagewhile minimizing the distortion created by the offset angle of theemission device. That is, the capture stage and X-ray emitter arecoordinated to minimize skew and maximize capture of both X-ray andfluoroscopic images. By moving the sensor within the stage, the userdoes not need to reposition the subject to get a clear, usable X-ray orfluoroscopic image.

In the case of a handheld emitter, wherein the emission device isphysically decoupled from the stage, it is important to position thesensor relative to the emitter for quality and safety reasons. Differenttechniques may be used to accomplish this goal. As shown in FIGS. 8 and10 , a plurality of position tracking implements 830 may be mounted tothe ends or corners of the tray. While these implements may be used inall four corners, only one is necessary for accurate triangulation.These implements may be based upon ultrasonic tone generation orinfrared emission. In these embodiments, acoustic or infrared signalsgenerated in the platform are detected by the emitter device, causingthe sensor to translate and tilt to maximize capture. A furtherembodiment may utilize magnetic position and orientation sensors anddetectors of the type used in surgical navigation to orient the tray andX-ray sensor.

The x, y, pan and tilt positioning of the tray and sensor may beaccomplished without position emitters in the platform portion of thesystem. FIGS. 12A and 13 illustrate an alternative system and method ofposition calculation that removes the dependency of having positionemitters embedded in the table. Instead, the position of the X-rayemitter in relation to the capture stage and X-ray detection sensor canbe calculated based on external position emitters. As noted above, theemitter can be purely handheld to allow a practitioner to move theemitter in free space. Alternatively, the emitter can be moveable with(or coupleable to) a support structure that maintains the emitter inposition relative to the object without requiring the physician tocontinuously hold the emitter.

The process to determine the location of the X-ray emission device inaccordance with this embodiment is as follows:

The external positional emission device(s) are installed onto a fixedlocation and contain a series of infrared emitters. This emission devicereleases infrared patterns from 5 sides of a cubic object 1202 resultingin infrared energy being sent out from slightly different origins.

The stage detects the infrared pattern and calculates the relativeposition from the stage to the center of each infrared emitter in3-dimensional space. This position will be considered [xsi, ysi,zsi]=[−xei, −yei, −zei] with s representing the stage, e representingthe infrared emission device, and i representing the index of theinfrared emission device (if leveraging multiple infrared emitters).

The X-ray emission device continually detects the infrared signalpatterns and determines the relative location of the emission device tothe center of each infrared emitter in space. This relative position isrelayed to an emission position control unit for each emitter. Thisposition may be considered [xhi, yhi, zhi]=[−xei, −yei, −zei], with hrepresenting the X-ray emission device, e representing the infraredemission device, and i representing the index of the infrared emissiondevice.

The emission position control unit will receive the relative positionsof the X-ray emission device ([xhi, yhi, zhi]). Using these relativepositions, the emission position control unit calculates the position ofthe X-ray emission device relative to the stage (FIG. 13 ), resulting in[xhi−xsi, yhi−ysi, zhi−zsi]. This operation is performed for eachinfrared emission device (i), which can then be used to deduce themargin of error.

After the stage applies the position along with the other pieces of dataas mentioned in the original filing, the stage moves and rotates theX-ray sensor plate into the correct position to capture the X-ray image.

FIG. 12B illustrates a variation where an emitter 710 can apply energyto a sensor/detector 706 that is configured to move as discussed hereinbut can also move to enable a lateral image. In the illustratedvariation, the sensor/detector 706 moves outside of the center X axis ofthe table 105 to capture lateral views of the patient 104. However,variations of the sensor 706 can include configurations where the tableis non-planar and is configured to receive the sensor 706 above a planin which the patient is positioned. FIG. 12B also illustrates anadditional concept where multiple detectors 706 are used as describedherein. In such a variation, the sensors 706 would be moved as describedherein, but the sensor having the best operational alignment would beused to generate a signal.

Safety Lockout Procedures

Just as it is important to limit emissions from the emitter to specifictarget distances, for a variety of reasons, both practical andcertification, it is important to only fire the X-ray generator when theemitter is properly aimed at the capture stage. By preventing the X-raygenerator from emitting photons while not pointed at the stage, thesafety of the system is improved and the performance of an emitter isincreased. FIG. 14 illustrates the process by which the device managesthe safety lockout of the emitter and captures an X-ray image, with thenumbers corresponding to the numbers in FIG. 14 :

-   -   1. User initiates the capture process by signaling through the        emission device 110, typically by depressing a trigger. The        emitter sends a data packet (D) to the controller containing the        request for capture, the distance measurements (d1, d2, . . . )        and the angle of the emitter.    -   2a. The controller validates that the emitter is in a safe        orientation.    -   2b. If the controller discovers that the emitter is not in a        safe, valid orientation, the controller sends an error message        to the emitter. This prevents the emitter from firing and        signals to the user that there is a problem.    -   3. The stage positions the sensor in accordance with the        position of the emitter. The stage will tilt the sensor so that        it is in the correct orientation to capture a clear image. The        orientation will be as close to the complementary angle of the        emission as possible.    -   4. The stage then sends a confirmation message to the controller        after the position has been established.    -   5. The controller forwards the start message to the emitter. The        emitter will then execute any additional safety or preparation        tasks. If the emitter believes the environment is safe to fire,        the emitter will then fire the X-ray.    -   6a. The emitter fires a pulse of X-ray photons at the stage for        the requested amount of time.    -   6b. During the emission of the X-ray photon stream, the emitter        constantly streams any updates to the position and angle to the        central controller.    -   6c. The controller records these positional updates and relays        them to the stage.    -   6d. The stage will rapidly and constantly update the position        and angle of the sensor to optically stabilize the X-ray image.    -   7. The sensor captures the emission of X-ray photons from the        emitter and builds an image.    -   8. Upon completion of the X-ray emission, the sensor relays the        data to the control unit.    -   9. The control unit then cleans up the image from the sensor        using a variety of known optical enhancement techniques. If        applicable, the control unit will leverage the stored movement        data from the emitter to further enhance the output.

The above process allows the emitter to ensure that the emission will bedirected at the sensor and the stage as opposed to any other arbitrarytarget. By moving the sensor into place below the emission target, theuser can create a resolute, flexible image of the exact desired portionof the subject without having to reposition the subject.

FIG. 15 illustrates the process by which the device captures afluoroscopic image. The process for capturing a fluoroscopic image isvery similar to capturing a static X-ray image; however, thefluoroscopic process will repeat several emissions and image captures tocreate a moving image. The process to ensure the safe emission as wellas capture the fluoroscopic image, with the numbers corresponding to thenumbers in FIG. 15 :

-   -   1. User initiates the capture process by signaling through the        emission handle, usually by depressing a trigger. The emitter        sends a data packet (D) to the controller containing the request        for capture, the distance measurements (d1, d2, . . . ) and the        angle of the emitter.    -   2a. The Controller validates that the emitter is in a safe        orientation.    -   2b. If the Controller discovers that the emitter is not in a        safe, valid orientation, the controller sends an error message        to the emitter. This prevents the emitter from firing and        signals the user that there is a problem.    -   3. The stage positions the sensor in accordance with the        position of the emitter. The stage will tilt the sensor so that        it is in the correct orientation to capture a clear image. The        orientation will be as close to the complementary angle of the        emission as possible.    -   4. The stage then sends a confirmation message to the controller        after the positioning.    -   5. The controller forwards the start message to the emitter. The        emitter will then execute any additional safety or preparation        tasks.

In the fluoroscopic mode, the emitter will repeat the following stepswhile the emitter device continues to request additional fluoroscopicframes, as follows:

-   -   6a. The emitter fires a pulse of X-ray photons at the stage for        the requested amount of time.    -   6b. During the emission of the X-ray photon stream, the emitter        constantly streams any updates to the position and angle to the        central controller. If at any time during the fluoroscopic        process, the operative stage detects the emission is not aimed        at the stage, the stage will send a termination signal to the        emission device and skip directly to step 9.    -   6c. The controller records these positional updates and relays        them to the stage.    -   6d. The stage rapidly and continuously updates the position and        angle of the sensor to optically stabilize the X-ray image.    -   7. The sensor captures the emission of X-ray photons from the        emitter and builds an image.    -   8. The sensor immediately transfers the image to the control        unit. At this time, a brief cleanup process is executed and the        image is displayed on the external viewing device. This        fluoroscopic frame is saved to memory.

The constant repetition of this process creates a moving image on theexternal display. The process will repeat until the user releases thetrigger of the emission device.

-   -   9. Once the user releases the trigger of the emission device,        the control unit “cleans up” the stored frames from the sensor        using a variety of known enhancement techniques. If applicable,        the control unit will also apply any stored movement data from        the emitter to further enhance the output. The control unit will        then combine the fluoroscopic frames into a single video for        repeated playback.

The above process allows the user to see a live fluoroscopic view of thesubject in real-time. By storing the images and reprocessing after thecapture is complete, the device can create a high-quality, singlefluoroscopic video for display and review at a later time.

Self-Adjusting Collimator

As noted above, the systems of the present disclosure allow for movingan emitting apparatus to a location relative to the object and determinea position of the emitting apparatus relative to at least one positiontracking element where the at least one position tracking elementmeasures a distance between the emitting apparatus and the object andpreventing emitting energy until the distance is less than apre-determined distance. Variations of the systems described herein canuse a self-adjusting collimator that optimizes a profile or boundary ofthe emission onto the working surface of a sensor. As with othervariations described herein, these systems can relay the position of theemitting apparatus to a motor system that adjusts an imaging sensor intoan operative alignment with the emitting apparatus, where relaying theposition of the emitting apparatus includes using the emitting apparatusto both provide an orientation data of the emitting apparatus anddetermine a distance from each of the plurality of tracking elements.However, the use of a self-adjusting collimator allows for automaticmaximization of an emission profile on the imaging sensor.

To illustrate the benefit of an adjustable collimator, FIG. 20illustrates a representation of an X-ray emitter 110 directed towards atable 114 having an imaging sensor (not shown) located therein. Theperimeter of the working area 116 of the imaging sensor is shown toillustrate the area that will produce an image upon exposure to an X-rayemission. As shown, a profile of an X-ray emission 120 from X-rayemitter 110 extends beyond the perimeter of the working area 116 of theimaging sensor causing the X-ray emitter to be out of operativealignment with the sensor. In such a case, the system as describedherein will not permit firing or initializing of the X-ray emitter 110.The illustration of FIG. 20 is intended to illustrate a concept of thesystem being out of operative alignment. As noted herein, the imagingsensor can be coupled to a motor system to permit movement of the sensorinto alignment with the emission profile 120. Alternatively, the table(or operating surface) 114 can include a plurality of position trackingelements (not illustrated in FIG. 20 ) that allows determination of theposition and distance of the emitter 110 relative to a non-moving sensoror the sensor's working area 116.

FIG. 21A represents a situation in which an emission profile 120 extendsbeyond the sensor 116 such that the emitter is not in operativealignment with the sensor 116. For purposes of illustration, the sensor116 shown in FIGS. 21A and 21B, is stationary and tracking elements 118permit the system to determine the relative location, orientation, anddistance of the emitter (not shown) relative to the sensor 116. Also,the emission profile 120 is illustrated as a representation of aboundary of the emission provided by the emitter. For purposes ofillustration, the profile 120 illustrated is a profile that would occurif an axis of the emitter is perpendicular to the sensor 116.

As noted herein, if the system cannot establish operative alignmentgiven the condition shown by FIG. 21A, the operator will be prompted toadjust the position of the emitter. In some variations, the system canprovide feedback such as an audible or visual indicator ofnon-alignment. FIG. 21B shows a situation after repositioning of theemitter such that the emission profile 120 falls within the boundary ofthe sensor 116. However, as shown, this emission profile 120 is notmaximized to the dimensions of the sensor 116. Failure to maximize theemission profile 120 relative to the sensor can require the operator totake additional radiological images of the subject to adjust for asmaller profile.

FIG. 22A illustrates the effect of an adjustable collimator. Again, forpurposes of illustration, the emission profiles shown representillumination by an emitter that is perpendicular to a sensor. FIG. 22Ashows an unadjusted emission profile 120 that would ordinarily beconsidered out of operative alignment with the imaging sensor 116 giventhat a portion of the emission area bound by the profile 120 fallsoutside of the sensor 116. However, a variation of the system describedherein will rely on the position tracking elements 118 as well ascomponents affixed to the emitter (as described above) to determinepositional information such as an orientation of the emitter as well asa distance between the emitter and the sensor 116. The system will usethe positional information to adjust a collimator on the emitter torotate and/or scale emission by the emitter to produce an adjustedemission profile 122. As shown, in this variation, the adjusted emissionprofile 122 is reduced in size (denoted by arrows 126) and also rotated(denoted by arrows 124) to scale the emission profile 120 into anadjusted emission profile 122 that maximizes an exposure onto theimaging sensor. It is noted that the adjusted emission profile can bescaled or rotated as needed. Moreover, variations of the system willproduce an adjusted profile during real-time movement of the emitterrelative to the sensors 118.

FIG. 22B illustrates an unadjusted emission profile 120 along with theadjusted emission profile 122, where in both cases, the profileresembles an isosceles trapezoidal shape due to an axis of the emissionpath not being perpendicular or normal to the sensor 116. However, inthis variation, the system uses the positional information to produce anadjusted profile 122 that maximizes an exposure area on the image sensor116.

While the variations disclosed herein rely on tracking elements 118 aswell as sensors within the emitting unit (as described herein).Variations of the system that produce an adjusted emission profile canalso be used with positional data that is derived from external cameras,sensors, or mechanical supports to determine relative movement betweenan emitting apparatus and an imaging sensor.

FIG. 23 shows a variation of an adjustable collimator 130 that can beused in or with an emitting apparatus (not shown in FIG. 23 ). Asillustrated, the adjustable collimator 130 can rotate and/or scale anaperture or emission window 132 to produce an adjusted emission profileupon an imaging sensor (as discussed in FIGS. 20 to 22B). This variationof the adjustable collimator 130 uses a number of blades or leaves 134that can move and rotate to adjust an orientation of the aperture 132.The blades 134 prevent passage of the emitted energy such that energy islimited to pass through the aperture or emission window 132.

The movement and rotation of the blades can be driven by any number ofmotors or drives. In the variation shown, the adjustable collimator 130includes a motor assembly having a first drive 138 coupled to a proximalslewing bearing 152 and a second drive 136 coupled to a distal slewingbearing. The drives 136 and 138 adjust the rotation of the blade 134 sas well as a sizing of the aperture 132. For example, rotation of themotors 136 and 138 in opposite directions causes rotation of the slewingbearings in the opposite direction and produces movement of the blades134 to cause opening/closing of the aperture 132. In the example shown,if the first drive 138 moves in a clockwise direction and the seconddrive 136 moves in a counter-clockwise direction, then the blades 134will move towards each other, causing a size of the aperture 132 todecrease. Likewise, if the first drive 138 moves in a counter-clockwisedirection and the second drive 136 moves in a clockwise direction, thenthe blades 134 will move away from each other causing a size of theaperture 132 to increase. If the drives 138 and 136 move in the samedirection, this will cause rotation of the proximal and distal slewingbearings 150 and 152 in the same direction, which will cause rotation ofthe blades, which causes rotation of the aperture 134.

The adjustable collimator 130 maintains an aperture 132 having anear-square shape since all of the blades 134 move to adjust the size ofthe aperture. Additional variations of the device can include any numberof additional motors or actuators to also control an angular orientationof the blades. In such a case, the aperture 134 is not limited to asquare profile and can assume an isosceles trapezoidal shape. Such afeature can assist in maintaining a square emission profile (such asthat shown in FIG. 22A) regardless of the orientation of an axis of theemission energy to the imaging sensor.

The variation of an adjustable collimator 230 shown in FIG. 23 alsoincludes a chassis or housing 140 that houses the drive mechanism (e.g.,bearings, pulley 144, belts 146, etc.) that translates the movement ofthe gears 144 driven by motors 136, 138 into rotation and movement ofthe blades. Furthermore, the adjustable collimator 230 will include anynumber of positioning tracking systems that enable the system tomaintain information regarding a size and rotational orientation of theaperture. For example, a first moveable disk (or encoder wheel) 142 isshown as part of an optical encoder system that can use any conventionallight source, sensor, mask, and photosensor (e.g., a photodiode).

FIGS. 27 and 28A-28B illustrate another aspect in which a radiologicalsystem having a sensor configuration as described herein can improve thequality of an X-ray or fluoroscopic capture.

The quality of an X-ray or fluoroscopic capture is related to a numberof physical attributes of the subject. These elements dictate a set oftechnique factors (e.g., power, current, time, etc.) that control theemission characteristics of the radiation source/emitter. It is theresponsibility of the device operator to set these factors in such acombination that the individual viewing the radiological image canidentify the necessary visual elements without exposing the subject toexcess radiation.

Setting these technique factors can be complex. In order to relieve theoperator of the burden of setting these techniques manually, existingfluoroscopic devices have implemented an automatic process. The typicalapproach uses a software or a hardware dose detector on the plate thatgradually fills as radiation is added to the exposure. This conventionalapproach has a number of problems.

One major issue with the conventional approach is movement. Because theradiation is exposing the subject for an extended time period, anymovement whatsoever, either in the subject, the operator, the machine,vascularity inside the subject, etc., creates motion artifacts thatseverely degrade the image.

Another issue is that penetration requirements are not known before theexposure; therefore, as the source emits radiation at a given powerlevel (kV), frequently, there is not enough penetration to render animage. This failure to render an image exposes the patient, operator,and staff to radiation without producing any useful radiological image.In such a case, these individuals are exposed to excess radiation thatdoes not serve any clinical purpose.

Innovation in the fluoroscopic device space, including but not limitedto the systems described herein, creates a new generation of machineswith complex sensor arrays capable of directly measuring a number of thephysical elements required for exposure calculation.

By utilizing these sensors across the full spectrum of devices andsubjects, as well as robust machine learning techniques, it is possibleto compute the necessary techniques before exposure, eliminating motionartifacts and creating an outstanding capture, all while reducing dose.

The following descriptions provide exemplary details of the invention inorder to provide an understanding of the invention. Small engineeringadjustments could be employed to practice the invention withoutemploying these specifics. While the invention is described for use inX-ray imaging for surgical purposes, it could be used in other medicalapplications, including but not limited to general medical imaging,veterinary, and bone densitometry. It could be used for non-medicalapplications such as industrial imaging, metal fatigue inspections,weld-inspection, for security inspections, and the like.

FIG. 24 shows a diagram of an example of a conventional methodology forautomatic X-ray exposure process. The doctor or operator begins theexposure (step 1) by requesting the X-ray be taken. The X-ray devicewill then evaluate the detector (step 2), tracking the amount ofradiation received on the imaging sensor plate. An internal measurementof X-ray machine will determine if this energy is a sufficient amount ofexposure to generate an image (step 3). If the device determines that anadequate amount of radiation is collected (step 4a), it will deem theexposure complete and display the X-ray. If the user cancels the X-rayor the dose has been accumulating for too much time, the machine willcancel the exposure (step 4b.) Otherwise, (step 4c)u, the device willcontinue to emit radiation, returning back to the evaluation step untilthe image is created, time runs out, or the user cancels the exposure.

The traditional process has a number of drawbacks. The two largest arethat: exposure begins without a guarantee that an image will appear andthat the time taken to evaluate the exposure introduces movementartifacts in the final image, creating an unusable X-ray. In eithercase, the patient, operator, and staff are exposed to unnecessaryradiation, which is a major safety hazard.

FIGS. 25 and 26 illustrate an improved approach over the conventionalmethodology described in FIG. 24 . The improved approach can determinethe optimal technique factors to create a resolute and effectiveradiological image without exposing the operator, staff, and patient tounnecessary or excessive radiation. By utilizing a radiological imagingdevice with a comprehensive sensor array and an enterprise-wideapplication of machine learning techniques, the system 20 can calculateand refine the techniques before any radiation is emitted. This allowsan operator to precisely align the device and understand if the machineis capable of imaging the anatomy.

FIG. 25 illustrates an example of how statistical data can be compiledfor use in the imaging process of FIG. 25 . In practice, a number ofstatistical models are transmitted to the system 20 from a centralserver (shown in FIG. 26 ). These models, referred to as the ComputerVision Classifier (1a) and the Estimator Update (1b), are stored locallyon the machine and ready for use prior to the operator requesting theexposure.

Turning to FIG. 25 , the process can begin with the operator initiatingthe capture (2). The operator then uses the positioning system of thedevice to align the emitter and anatomy (3), completing the safetychecks, then executing the automatic technique detection (as describedabove). Depending on the exact topography of the X-ray system, CPT Codeinformation (4a) and or Biometric Information (4b) may be entered by anoperator or extracted from another system by automatic means.

As the system prepares to emit the energy for either X-ray orfluoroscopic capture, two concurrent measurement collections arehappening: on-device sensor collection (5a) and computer visionclassification (5b).

The sensor collection uses the array on the device to collect amultitude of input parameters, including, but not limited to,source-to-skin distance (SSD), source to detector distance (SDD), angleof incidence, ambient, X-ray tube and device temperature, etc. Theseparameters are all fed into the inference execution function (6).

The computer vision classifier utilizes the imaging camera on the deviceto capture pictures of the subject anatomy. These images are passed intothe CV analysis function, using the captured images as well as the CVClassifier data that is stored locally on the device provided by thecentral server. These processes make a determination about that subjectof the capture and passes that recommendation to the Inference ExecutionEngine.

Once the inputs are collected from the device's various subsystems,those values, along with the Estimator Update provided by the centralserver, are run against the device's inference execution engine (6a).The output of that function family is the determined X-ray technique:time, kV and beam current (7).

The device output is set to the computed values, radiation is emittedfor the given settings (8), the image is captured and processed (9) andthe image is displayed to the user. (10)

As soon as the X-ray is displayed to the operator, the systemimmediately begins monitoring the operator interaction in theInteraction Monitoring system (11). This system records everyinteraction the operator has with the image, which includes changes inbrightness, sharpness, contrast, position, zoom, rotation, etc. Theamount of time the operator spends examining the X-ray or fluoroscopiccapture is also recorded.

In steps 12a-12d, the system will submit capture data to the centralprocessing system. The submitted data includes the four major componentsof the capture: (12a) Direct Measurement Information, such an SSD,temperature, etc. (12b) interaction heuristics, such as the changes inbrightness or the amount of time spent examining a capture. (12c)includes the surgical detail, such as the biometric information, anyassociated CPT code, as well as the computer vision captures andresulting classification output. (12d) includes the raw capture datafrom the detector itself as well as capture associated information, suchas machine details, software versions, etc.

This capture information is stored on the central processing system inrespective databases 13a and 13b for future processing.

At a scheduled time, the central processing system will train theestimator labels (14) using a sophisticated regression analysis. Byexamining the statistical relationship between the sensor data, capturedata and surgical data across a large section of universally capturedX-rays, as well as the results of the previous estimator generation(14a), the system can fit data to more accurate labels. The output ofthe training step is a new estimator (17).

Like the label training step (14), the X-ray and fluoroscopic capturedata, surgical detail data and classifier data will be trained using aclassifier refinement process (15). This process uses the large capturecross-section from the huge number of input X-rays to create a moreaccurate classifier (16).

Depending on the topography of the X-ray machines in the field, thecentral processing system will transmit the new estimator (18) andclassifier (19) to the devices as soon as possible. They will then loadthese updates into the device local storage (1a) and (1b) and apply thenew algorithms to further enhance the accuracy and reduce the dose ofthe automatic exposure.

FIG. 27 shows an additional variation of an X-ray system usingnon-line-of-sight-tracking-elements such as electromagnetic trackingsensors 252. Although the example of FIG. 27 shows 4 sensors 252, anynumber of sensors 252 can be used as required. While the system canoperate with a single sensor 252, additional sensors can be used forredundancy. In operation, the electromagnetic sensors 252 generate anelectromagnetic field to create a tracking space within a defined region(e.g., the operating tablespace 250) about a perimeter of the X-raysensor 254. The emitter 110 includes one or more receivers thatinductively couple with the magnetic field generated by the sensors 252.Since the sensors 252 allow for non-line-of-sight tracking of theemitter 110, the sensors 252 can be positioned within the working space250. Alternatively, the sensors 252 can be visible, or their positioncan be marked on or around the working space 250. The ability ofnon-line-of-sight tracking allows for full-body imaging applications.Additionally, the non-line-of-sight tracking permits reducing the sizeof the structure housing the X-ray sensor 254. Any number ofelectromagnetic tracking field emitters and sensors can be used as analternative or in addition to the tracking emitters discussed above.

Electromagnetic sensors and their operation are discussed in U.S. Pat.Nos. 4,054,881; 6,762,600; 6,624,626; 6,400,139; 6,377,041; and6,369,564 the entirety of each of which is incorporated by reference.Such electromagnetic tracking systems are available from Polhemus(Vermont, USA) and NDI (Ontario, Canada).

Electromagnetic tracking systems (EM systems) can be very sensitive tointerference from prevailing metallic objects or inductive motors.Accordingly, variations of an X-ray system using an EM system willadditionally include one or more inertial measurement units (IMUs). Inuse, the X-ray system with EM tracking starts in a calibrated state.This calibration is held over from previous use or comes calibrateddirectly from the factory. As the X-ray system is in use, tracking ofthe X-ray emitter relative to the X-ray detector is accomplished by boththe EM sensors and any IMUs. Typically, one or more IMUs are placed inthe X-ray emitter and (optionally) an IMU placed in the X-ray detector.EM tracking and the differential positioning data supplied by the IMUswill generally line up. If at any point, both data sets do not align,the system can infer transient interference in the EM system and signalan error state. During this error state, the system can use the IMU datato smooth out any interference and generate a best-most-likelypositioning state. Typically, this inference is sufficient to smooth theEM data and maintain system functionality. As the transient interferencesubsides, the IMUs data and EM sensors data will fall back intoalignment.

In an additional variation, an X-ray system with EM tracking can use theX-ray emission to actively and continuously update the calibration. Insuch a case, collimation/beam angle of the X-ray emission from theemitter permits identification of the true position of the X-ray emitterwhen the emission was released through computer processing. The systemcan then use the true position calculated from the emission to determineif any offsets to the EM positioning system are required.

FIG. 28 illustrates another variation of an imaging system as describedherein that uses a portable X-ray emitter 110. The X-ray emitter 110 canbe free-standing or can be attached to a boom-type structure that allowsfor up to six degrees of freedom. As discussed above, the X-ray emitter110 is configured with a positioning system using any number of positiontracking elements 264 that are positioned around a perimeter of animaging sensor 262 that receives an X-ray emission from the emitter 110to produce an X-ray image. The imaging sensor 262 can be located in ahousing 260 that comprises a working area for positioning of the objectto be imaged. Alternatively, the sensor 262 can be positioned in a tablestructure or other structure as discussed above.

The position tracking elements 264 communicate with an X-ray positioningcontrol system 266 that is configured to determine the relative locationof the image sensor 262 and emitter 110. The X-ray positioning system266 can be any of a variety of positioning systems including but notlimited to the positioning system as described herein and can useline-of-sight emitters, non-line-of-sight sensors, or a combinationthereof.

The system shown in FIG. 28 also illustrates the emitter 110 as havingone or more cameras 282 adjacent to an emitter window 280. Variations ofthe system can include an emitter 110 as having dual stereoscopiccameras 282, 284 positioned about the emitter window 280. Alternatively,a single camera 282 or 284 can be used. As shown, the emitter 110 canoptionally include lidar sensors 286 for additional positioning,imaging, and depth-sensing functionality, as well as any additionalsensors disclosed herein.

The camera(s) 282 and/or 284 transmit signals to a processing unit 268,which produces an image of the field of view from the emitter 110 usingthe camera signal. The processing unit 268 is also configured to use thepositioning data from the positioning system controller 266 to generatea first virtual representation of the imaging sensor 262 and overlaysthis image onto the image of the field of view from the emitter 110 asdiscussed below. The image and the first virtual representation of theimaging sensor 262 can be viewed on one or more display units 270. Inone variation, the display unit 270 comprises a screen on a portion ofthe emitter 110. Alternatively, or in combination, the display unit canbe a monitor within the examination area. In addition, the processingunit 268 can allow for broadcasting of the virtualized image to allowfor remote viewing of the virtualized image. In additional variations,the X-ray positioning system 266 can be combined with the processingunit 268.

FIGS. 29 and 30 illustrate initial stages of an attempt to capture anX-ray image of an individual patient 104 that is adjacent to an imagesensor 262 of an image sensing housing 260 where the individual patient104 obscures a majority of the housing 260 and/or image sensor profile262. The illustration shown is for explanatory purposes as the sameprinciples apply if the image obtained was a body portion (e.g., a leg,shoulder, torso, etc.) where the body portion obscures the image sensor262 such that an operator of the X-ray cannot visually confirm alignmentof the body/body portion on the housing 260 with the image sensoroutline 262. FIG. 30 illustrates where a projection of an X-ray emission290 would produce an emission projection area 292 on the individual 104.However, in some variations, the X-ray system allows the operator todetermine an outline of the projection area 292 using a light-fieldgenerated by the emitter 110. This allows the operator to visualize thearea of the X-ray emission without generating X-ray radiation.

As shown in FIG. 30 , because the X-ray detector housing 260/sensor 262is obscured by the patient's torso 104, the operator can inadvertentlyincorrectly position the X-emitter 110 such that the emission projectionarea 292/light field is, unknowingly, misaligned with the image sensor262. This misalignment results in an X-ray image having a compromisedfield-of-view the projection area 292. Positioning of the camera 282adjacent to the emitter window 280 permits the camera to obtain asimilar field-of-view as the emitter window 280. In variations of thesystem, the camera(s) 282 can use image stabilization or actuators toshift a perspective of the camera image so that the camera image isalways displayed normal to the image sensor.

FIG. 31 represents a display of a first virtual representation 274 ofthe boundary of the imaging sensor 262 on the display 270. As shown, theimage 272 allows an X-ray user to observe the area of the individual 104that is aligned with the imaging sensor 262. The image 272 can be astill capture image, real-time video, or a video segment when the useractuates a setting prior to emitting X-ray energy from the emitter. Asshown, the point-of-view of the camera 282 will match or be sufficientlyclose to a point-of-view of the emitting window 280 such that the image272 view corresponds with the ultimate X-ray image. The system shown inFIG. 31 can also optionally show a light field (as shown in FIG. 30 ) onthe patient 104 as well as a virtual representation of the lightfield/X-ray projection area on the monitor 270 prior to dischargingX-ray emission from the emitter.

FIGS. 32 and 33 show additional examples of images 272 overlayed withvirtual images 274 of the boundary of an imaging sensor. FIGS. 32 and 33also show second virtual images 276 that represents the area of X-rayradiation emitted from the emitter that will be incident on theindividual and image sensor. If the system uses a light-field projectionfrom the emitter, the second virtual image 276 can correspond to thelight-field projection on the patient. In this way, the operator can useboth virtual images 274 and 276 to ensure that the intended object ofthe X-ray image is within the overlapping areas. FIG. 32 illustrates acondition where the emitter (not shown in FIG. 32 ) is in a normaldirection to the object and the image sensor. FIG. 33 illustrates avariation of a system where the camera image 272 is shifted inperspective to appear normal to the patient and image sensor eitherthrough movement of the camera on the emitter or via digital processingof the image. However, FIG. 33 shows skewing of the projected X-rayprojection area through skewing of the second virtual image 276representing the X-ray emission area. This feature allows a user torecognize that the emitter is not positioned in a normal directionrelative to the object when viewing the monitor 270.

FIG. 34A shows another variation of an X-ray system using bothnon-line-of-sight-tracking elements such as electromagnetic trackingsensors 252 and line-of-sight elements 264 as described above. Again,any variation of the system disclosed herein can include eithernon-line-of-sight tracking elements, line-of-sight tracking elements, ora combination of elements. FIG. 34A also illustrates an X-ray emitter110 having a screen 270 on an end of the unit 110 opposite to a body 111that carries the hardware and emitting apparatus of the unit. In such anexample, the emitter window is located on the bottom face of the body111 such that a field of view 290 of an emission or camera is directedaway from the body 111, as shown by 290. The emitter 110 operates asdiscussed herein where any number of sensors 252 and/or 264 can be usedas required. In operation, the sensors 252 and/or 264 allow the system266 to determine the relative location of the emitter 110 relative tothe image sensor 254. As discussed above, the emitter 110 includes oneor more cameras (not shown in 34A) that transmit signals to a processingunit 268, which produces an image of the field of view from the emitter110 using the camera signal that can be displayed on the emitter 110 viaa monitor 270 or on a separate monitor. In the variation of the emitter110 shown in FIG. 34A, the emitter includes a first trigger 113 and asecond trigger 115 that allow a user to grip the emitter in differentconfigurations depending on the X-ray image required. Moreover, theemitter 110 can include any number of features (e.g., a side contour,graphic, etc.) to provide a physical visual indicator to show where theX-ray emission exits the emitter 110.

FIGS. 34B and 34C illustrate the emitter 110 shown in FIG. 34A, where agrip portion 119 of the emitter 110 is located between the body 111 andthe monitor 270. This configuration permits operation of the emitter 110in two different configurations. FIG. 34B shows a configuration wherethe emitter 110 is held over the object/patient such that the field ofview 290 of the emission and camera exits in a bottom direction. In sucha case, the operator can view the image 272 as well as the virtual image274 of the image sensor on the monitor 270 while using a control switch306. The first activation trigger (shown in FIG. 34A) can be accessed bythe same hand grasping the grip portion 119. In FIG. 34C, the operatorpoints the bottom of the body 110 in a direction to the object beingimaged, as shown by field-of-view 290. In this variation, the operatorcan view the monitor 270 and adjust the control knob 306 while accessingthe second trigger 115 with a thumb. It is noted that the monitor shownin FIGS. 34A to 34C can provide the same information as shown in FIG.33A or 33B.

Another aspect of the system and methods includes simultaneous captureof a digital photograph (through the camera) and a corresponding x-rayimage of an area of interest. Mating of the digital image to itscorresponding X-ray image is useful for documentation purposes andenables future AI workloads and classifier algorithms to better identifythe orientation and anatomy of the x-ray image. Moreover, without matingof a digital image with a corresponding X-ray image, an operator,observing a previously taken X-ray image, is forced to use a best guessas to the orientation and alignment of the X-ray source to the x-raydetector for that previous image. Unfortunately, this frequently causesa need for a reshoot. It is estimated that over 22% of reshoots are dueto simple positioning errors. The ability to merge an X-ray with adigital image of the object/body part can improve outcomes of anysubsequent X-ray images. In another aspect of the systems and methods,the imaging system can include a depth-sensing camera. For example, theemitter can include a LIDAR array (e.g., 256 pixels) determines depth.This depth (thickness) and shape of the anatomy can be used to refinethe size of the anatomical illustration.

FIG. 35 illustrates another aspect of the systems and methods forimproving the ability of an operator to take an X-ray image. Asdiscussed above, systems and devices of the present disclosure can use apositioning system to show a dynamic view of the X-ray detector 262through a display 270. In the variation shown in FIG. 35 , an emitter110 includes a large display 270 that allows for the operator to observea real-time, dynamic view of the working surface 260/imaging sensor 262.As illustrated, the display 270 can be segmented to provide multipleviews of different information rather than a single window. For example,and as shown, the display 270 can show previous X-ray images oradditional information as discussed below. The emitter 110 is shown inFIG. 35 comprises a tablet-like form where the rear side 170 includescomponents, including but not limited to an emitter window, one or morecameras, a lidar or similar component, etc. The emitter-tablet 110 canalso include any number of ergonomic features, such as a finger/handopening 174 that allows ease of positioning of the emitter 110 andergonomic access to controls 172. In an additional variation, theinformation provided on any display associated with the emitter 110 canalso be provided on an external display or monitor that is separate fromthe emitter 110 unit.

FIG. 36A illustrates an example of a system as described in FIG. 35 withvarious information displayed in a display 270 of the tablet-emitter110. It is noted that while the system described herein can include theuse of a positioning system (described above), the features andinformation provided in any visual display 270 can be applied to anyX-ray system, including but not limited to a traditional c-arm imagingsystem. Again, the rear side of 170 the table-emitter 110 includes oneor more apertures for an emitter, camera lens, lidar, or othercomponents shown on the emitter of FIG. 32 . Moreover, the camerasystem/lens can be configured to take an image or video from aperspective that matches or is close to the perspective of any X-rayimage taken by tablet-emitter 110.

FIG. 36A illustrates the display 270, including a number of subsetdisplays 180, 182, 184, and 186. These displays can provide informationin information displays 180 regarding the patient, physician, or otherdata that is associated with the patient and/or X-ray image. The display270 can also include informational displays 184 to guide the operatorwhen taking the X-ray image. The display 270 can also include a workingdisplay 182 that allows real-time visualization of the workingsurface/enclosure 260 that houses an imaging sensor (not shown) as wellas a first virtual image 274 representing the imaging sensor as well asecond virtual image 276 representing the area of X-ray radiation to beemitted from the emitter 110 that will be incident on the image sensorand/or individual. The display 270 shown also includes an X-ray display186, which can be used to display the X-ray obtained during theexamination. In this illustration, the X-ray display 186 is blank.

The subset displays shown in FIG. 36A are exemplary only, and thedisclosure includes any combination of subset displays as well as asingle display. Typically, the operator can change displays usingcontrols 172 on the unit.

While FIG. 36A illustrates a condition prior to taking an X-ray, FIG.36B illustrates a state where the operator receives informationregarding the type of X-ray image required. As discussed below, theinformational display 184 can display information to the operator, suchas a setup image that shows the ideal positioning of the individual104/body part. The setup image can also optionally show suggestedpositioning of the operator, emitter, and/or any accessories. While theimage shown in FIG. 36B also shows a suggested orientation of anemitter, and alternate images are within the scope of this disclosure.For example, the informational display can also show an exemplaryorthogonal photo of a picture of the desired anatomy, which gives theoperator a preview of how the subject/anatomy being examined shouldappear in the viewfinder/working display 182.

FIG. 36B also can include a virtual or vector anatomical representation190 of the desired position of a body part that is intended for imagingby the system. This virtual anatomical representation 190 can comprise avector rendering of the orthogonal image, setup image, or can comprise aseparate virtual image. Regardless, the virtual representation 190 isintended to assist the operator in positioning the patient prior toX-ray capture.

FIG. 36C illustrates positioning of a patient's body part 109 using thevirtual representation 190 such that the operator can proceed with X-rayimage capture to produce an X-ray image 186. As noted herein, providingthe operator with such information allows for individuals with minimaltraining to capture X-ray images that are typically required whenperforming an evaluation of an individual. Moreover, variations of thesystem can compare the captured X-ray image 186 to any appropriatereference image from the library discussed above. The system can includethe use of artificial intelligence to compare the captured X-ray image186 to a reference X-ray image and provide a score to guide the operatoras to the desirability of the captured X-ray image. In some variations,the system can prompt the operator to re-capture an additional X-rayimage using different positioning and/or X-ray emission settings.

It is noted that any of the virtual representations (e.g., 190, 274,276, etc.) can be triggered on or off depending on the operator'spreference. Moreover, the system further includes the option ofproviding a visual representation of only the overlapping regions of190, 274, 276 so that the operator ensures alignment of the body partand emitter with the image sensor.

The systems and methods described herein that provide visual images, aswell as virtual images, provide real-time, dynamic views to giveoperators a picture of the anatomy imaged before generating the X-ray.In addition, the systems can guide the operator to specific X-ray viewsby overlaying a diagram of the subject anatomy directly on the imagedisplay and view, corrected for the active area of the image sensor.Such a system can increase clinical use of the systems in those caseswhere the operator is not a physician or experienced X-ray technician.

For example, the reference images can help a user capture the best viewsor those views commonly required for assessment of a body part.Accordingly, the system can be networked with a database or library ofdata that guides an operator in taking one or more proper X-ray images.

For example, this database can include a library of images as well asother instructional materials to aid the operator. For example, thelibrary can include a view name, any number of reference X-ray images,any number of reference photos, and any number of patient alignmentphotos. One goal of such information is to give the operator a visualguide of the anatomy imaged before generating the X-ray.

FIG. 37A illustrates one example of a description of a data element orrecord 312 that is part of a database intended for interaction withX-ray imaging systems. As noted herein, the database and visual displaycan be used with systems that track positioning of the emitter relativeto the image sensor. Alternatively, the database and images can be usedwith traditional X-ray equipment, including but not limited to C-Arms,or other radiographic equipment.

FIG. 37A shows an exemplary record 312 separate data fields. Forexample, such data fields can include: a view name 314, anatomy 316, oneor more reference x-rays 318 (such as an image from an academic or otherreference sources), settings for the system in communication with thedatabase (so that the operator does not need to adjust settings fordifferent captures), reference X-ray images taken by the system orsimilar systems 322, orthogonal images 324, setup images 328, andaccessory information 328. The listing of data fields is intended forillustrative purposes only. Any combination of data fields or additionaldata fields are within the scope of this disclosure.

FIGS. 37B and 37C illustrates an example of three records 312, eachhaving various data fields comprising descriptive text (314, 316, 328,330), X-ray system settings (320), X-ray reference images (318, 322),and visual images (324, 326). In one example, where a caregiver requiresX-ray images for a follow-up examination of a patient, the system canreceive records 312 from an appropriate database. Records 312 are thendisplayed as noted above to guide the operator to obtain the imagesdesired for the follow-up examination. As noted above, the individualrecords 312 can be standard X-ray views, or a caregiver can selectdesired records to select the desired X-ray images. In an additionalvariation, an operator is initially examining an individual (e.g., in afield setting such as ordinary patient intake, an accident site, ortriage situation), the operator can indicate the anatomy requiring anexam, and the system can then pull or receive relevant records to guidethe operator into taking the required X-ray images.

The information discussed above in FIGS. 37A to 37C is an example ofradiographic imaging information that can assist an operator inobtaining a proper radiographic image and/or operate the X-ray emitter110 and/or X-ray system.

FIG. 38 comprises an additional variation of a display 270 configured toassist an operator to obtain a radiographic image at an initialscreening of an individual. In this example, the operator is providedwith an anatomic representation 240 that allows the operator to selectany number of anatomic regions to receive information that will assistin obtaining the desired X-ray. The operator can then select one or moreanatomic regions that require X-ray imaging. As an example, in thevariation shown in FIG. 38 , the operator selects the ankle area 242 onthe anatomic representation 240. Accordingly, the operator can then beprompted with various informational images from a database or library asdiscussed above, such as those shown in FIG. 37B, which show variousstandard positions of the ankle required to obtain X-ray images.Accordingly, the operator can follow position the individual's ankleusing the informational displays as well as any virtual overlays asdiscussed above to obtain a X-ray image for later assessment by amedical caregiver.

An alternate variation of the display 270 can include an anatomicrepresentation 240 that comprises textual information to allow theoperator to identify an antomic area. In addition, the anatomicrepresentation 240 can comprise a subset of an anatomic region insteadof the entire body.

The display 270 of FIG. 38 can also include various additional data,including but not limited to patient data 244, operator/physician info245, a database of patients 246 that are scheduled for examination, aswell as a historical section 247 of previous X-ray captures by theoperator.

The systems and methods described herein that provide visual images, aswell as virtual images, provide real-time, dynamic views to giveoperators a picture of the anatomy imaged before generating the X-ray.In addition, the systems can guide the operator to specific X-ray viewsby overlaying a diagram of the subject anatomy directly on the imagedisplay and view, corrected for the active area of the image sensor.Such a system can increase clinical use of the systems in those caseswhere the operator is not a physician or experienced X-ray technician.

In yet a further variation of the system, the system can include one ormore processors that use artificial intelligence to match the capturedX-ray image with the reference image 318 and/or template image 322 todetermine if the captured X-ray matches a reference image of therequested X-ray. If the artificial intelligence provides a sufficientmatch (e.g., via a similarity score), the operator can move on tocapture subsequent images. If the match is insufficient, the system canalert the operator to re-take the image.

While the above descriptions provide exemplary details of the inventionin order to provide an understanding of the invention, routineengineering adjustments may be employed to practice the inventionwithout departing from the spirit or scope of the invention. Further,while the invention is described for use in X-ray imaging for surgicalpurposes, it could be used in other medical applications such as generalmedical imaging, veterinary, and bone densitometry. The system andmethod may also be used for non-medical applications such as industrialimaging, metal fatigue inspections, weld-inspection, for securityinspections, and the like.

1. A method of obtaining a radiological image of an individual or a bodypart by an operator, the method comprising: positioning an emittingapparatus at a distance from a working surface, where the workingsurface includes an imaging sensor, the emitting apparatus including acamera system and an aperture opening configured to pass an emissionenergy therethrough; orienting the emitting apparatus such that theaperture opening and the camera system face towards the working surface;transmitting a signal from the camera system to a display to produce animage of the working surface on the display; providing at least oneinformational image on the display for viewing by the operator, wherethe at least one informational image comprises a suggested positioningof the individual or the body part; and emitting the emission energy tothe imaging sensor to produce the radiological image of the individualor the body part and displaying the radiological image on the display.2. The method of claim 1, wherein the display is positioned on theemitting apparatus.
 3. The method of claim 1, further comprisingproviding a virtual anatomical representation of the body part on theimage, where the virtual anatomical representation is overlaid on theworking surface on the image.
 4. The method of claim 3, furthercomprising positioning the body part on the working surface using thevirtual anatomical representation.
 5. The method of claim 1 wherein theimaging sensor comprises a detecting perimeter, the method furthercomprising displaying a virtual detecting perimeter on the display,where the virtual detecting perimeter is overlaid on the working surfaceand corresponds to the detecting perimeter.
 6. The method of claim 1,further comprising displaying a virtual emission perimeter on thedisplay, where the virtual emission perimeter is overlaid on the workingsurface and corresponds to an emission perimeter of the emission energyfrom the aperture opening.
 7. The method of claim 1, wherein providingat least one informational image further comprises providing aninstructional message on the display.
 8. The method of claim 7, whereinthe instructional message comprises a text instruction or a videoinstruction.
 9. The method of claim 1, wherein the image comprises avideo image.
 10. The method of claim 1, wherein the image comprises atleast one non-video image.
 11. The method of claim 1, further comprisingproviding an informational data on the display, where the informationaldata comprises a data associated with the individual.
 12. The method ofclaim 1, wherein the display comprises a plurality of subset displays,wherein the image of the working surface is displayed on a first subsetdisplay and wherein the radiological image is displayed on a secondsubset display.
 13. The method of claim 12, wherein at least oneinformational image is displayed on a third subset display.
 14. Themethod of claim 1, wherein providing at least one informational imagecomprises selecting one or more images from a first database containinga plurality of radiographic imaging information.
 15. The method of claim1, further comprising prior to positioning the emitting apparatus,displaying an anatomic representation on the display, the anatomicrepresentation having one or more anatomic areas, where the display isconfigure to permit the operator to select one or more of anatomic areasto pre-select the at least one informational image provided on thedisplay for viewing by the operator.
 16. The method of claim 1, furthercomprising performing a comparison of the radiological image to areference radiological image and providing feedback to the operatorbased on the comparison.
 17. A method of obtaining a radiological imageof an individual by an operator, the method comprising: providing anemitting apparatus having a display, a camera system, and an apertureopening configured to pass an emission energy therethrough; displayingan anatomic representation on the display, where the anatomicrepresentation includes one or more anatomic areas, where the display isconfigure to permit the operator to identify a selected anatomic areafrom the one or more anatomic areas; providing at least oneinformational image on the display for viewing by the operator, wherethe at least one informational image corresponds to the selectedanatomic area, where the at least one informational image comprises asuggested positioning of a body part corresponding to the selectedanatomic area; positioning the emitting apparatus at a distance from aworking surface, where the working surface includes an imaging sensor;orienting the emitting apparatus such that the aperture opening and thecamera system face towards the working surface; transmitting a signalfrom the camera system to a display to produce an image of the workingsurface on the display; and emitting the emission energy to the imagingsensor to produce a radiological image of the body part and displayingthe radiological image on the display.
 18. The method of claim 17,further comprising providing a virtual anatomical representation of thebody part on the image, where the virtual anatomical representation isoverlaid on the working surface on the image.
 19. The method of claim17, further comprising positioning the body part on the working surfaceusing the virtual anatomical representation.
 20. The method of claim 17,wherein the imaging sensor comprises a detecting perimeter, the methodfurther comprising displaying a virtual detecting perimeter on thedisplay, where the virtual detecting perimeter is overlaid on theworking surface and corresponds to the detecting perimeter. 21-40.(canceled)